First Biologic Approved in the EU for Gouty Arthritis - - BioPharm International

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First Biologic Approved in the EU for Gouty Arthritis



Ilaris (canakinumab), a selective, fully human, monoclonal antibody that inhibits interleukin-1 beta (IL-1 beta), has been approved in the EU for symptomatic pain relief in patients suffering from gouty arthritis whose condition cannot be managed with current treatments. Approval was supported by data from two Phase III trials, which demonstrated that patients treated with Ilaris experienced significantly greater pain relief compared to the injectable steroid triamcinolone acetonide. Adverse events were mainly mild to moderate, with infections of the upper respiratory tract and nasopharyngitis being the most frequent.

Ilaris, developed by Novartis, is administered in a single, subcutaneous injection of 150 mg. This is the first biologic approved by the European Commission for a gouty arthritis indication. The EC also granted an additional year of data exclusivity to Novartis based on the significant clinical benefit over existing treatments demonstrated for Ilaris.

"The approval of Ilaris for acute gouty arthritis attacks in patients without appropriate treatment options provides new hope for those debilitated by this excruciating condition," said David Epstein, division head of Novartis, in a press release. "Ilaris targets interleukin-1 beta, a key player in gouty arthritis inflammation. Our vision is to realize the potential of Ilaris wherever IL-1 beta plays a key role and available treatment options don't give patients the help they need."

Gouty arthritis, commonly known as gout, is a serious, chronic and progressive inflammatory disease affecting 1 to 4% of adults. Gouty arthritis attacks occur when the body produces a strong inflammatory response to uric acid crystals forming in the affected joints of the toe, foot, ankle, or knee. This disease is associated with a high prevalence of comorbidities, including hypertension, kidney disease, diabetes, dyslipidemia and cardiovascular disease, which can consequently lead to contraindications for existing therapies and complications for disease management.

Ilaris, the only approved fully human monoclonal antibody targeting IL-1 beta, is being investigated in a number of rare inflammatory conditions, including systemic juvenile idiopathic arthritis (SJIA), tumor necrosis factor receptor-associated periodic syndrome (TRAPS), colchicine-resistant familial Mediterranean fever (FMF), and cardiovascular disease. The agent has been approved in more than 60 countries, including in the EU, US, Switzerland and Japan for the treatment of cryopyrin-associated periodic syndromes (CAPS).

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